Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?

• ClinicalTrials.gov Identifier: NCT01786330
• Recruitment Status: Completed
• First Posted: February 7, 2013
• Results First Posted: April 11, 2016
• Last Update Posted: April 11, 2016
• Sponsor: Zachary Kuhlmann, DO
• Information provided by (Responsible Party): Zachary Kuhlmann, DO, University of Kansas Medical Center

Study Description

Brief Summary:

This is a pilot study investigating the use of abdominal binders after cesarean sections. The researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. Blood loss and pain control are both concerns after giving birth. It is hoped that the use of an abdominal binder after giving birth will provide a non-pharmacologic way to to reduce blood loss and manage pain.

Condition or disease	Intervention/treatment	Phase
Postpartum Hemorrhage; Pain	Device: Procare abdominal binder; Other: Standard of Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?
• Study Start Date: February 2013
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.	Device: Procare abdominal binder
Active Comparator: Control; Group receives standard of care	Other: Standard of Care

Outcome Measures

Primary Outcome Measures :

1. Lowest Pain Level Postoperative [ Time Frame: 24 hours postoperative ]
   SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Lowest pain level is reported as means for each participant group.
2. Average Pain Level Postoperative [ Time Frame: 24 hours postoperative ]
   SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Reported average pain level is reported as means for each participant group.
3. Worst Pain Level Postoperative [ Time Frame: 24 hours postoperative ]
   SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Worst pain level is reported as means for each participant group.

Secondary Outcome Measures :

1. Change in Hemoglobin Concentration [ Time Frame: 24 hours from baseline ]
   Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 39 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Cesarean section at term (at least 39 weeks gestation) scheduled in advance
• Singleton gestation confirmed by ultrasound in the current pregnancy
• Body mass index 20-40 kg/m2 (at first prenatal visit or pre-pregnancy)

• None of these pregnancy complications in the current pregnancy:

  1. bleeding disorder or use of anticoagulants other than low-dose heparin
  2. abnormal placenta (placenta previa or accrete)
  3. Preoperative hemoglobin less than 10 mg/dL
  4. Chorioamnionitis (intrauterine infection)
• No chronic pain syndrome (defined as participating in formal chronic pain management within the past year)
• Able to read English and understand spoken English

Exclusion Criteria:

• Onset of labor prior to time when the cesarean was scheduled

• Complications during performance of cesarean or discovered during cesarean:

  1. placenta accreta, increta, or percreta
  2. vasa previa
  3. cesarean hysterectomy required for severe hemorrhage
  4. organ damage during cesarean (cystotomy, enterotomy, ureteral injury)

Contacts and Locations

Locations

United States, Kansas

Kansas School of Medicine-Wichita

Wichita, Kansas, United States, 67214

Wesley Medical Center

Wichita, Kansas, United States, 67214

Sponsors and Collaborators

Zachary Kuhlmann, DO

Investigators

• Principal Investigator: Zachary Kuhlmann, DO; University of Kansas Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zimpel SA, Torloni MR, Porfírio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9:CD011216. doi: 10.1002/14651858.CD011216.pub2.

• Responsible Party: Zachary Kuhlmann, DO, Principal Investigator, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT01786330
• Other Study ID Numbers: 220121565; 12-049
• First Posted: February 7, 2013
• Results First Posted: April 11, 2016
• Last Update Posted: April 11, 2016
• Last Verified: March 2016

Additional relevant MeSH terms:

Postpartum Hemorrhage; Hemorrhage; Pain, Postoperative; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Uterine Hemorrhage